Protocol for Improving Care by FAster risk-STratification through use of high sensitivity point-of-care troponin in patients presenting with possible acute coronary syndrome in the EmeRgency department (ICare-FASTER): a stepped-wedge cluster randomised quality improvement initiative.

Introduction: Clinical assessment in emergency departments (EDs) for possible acute myocardial infarction (AMI) requires at least one cardiac troponin (cTn) blood test. The turn-around time from blood draw to posting results in the clinical portal for central laboratory analysers is ~1-2 hours. New generation, high-sensitivity, point-of-care cardiac troponin I (POC-cTnI) assays use whole blood on a bedside (or near bedside) analyser that provides a rapid (8 min) result. This may expedite clinical decision-making and reduce length of stay. Our purpose is to determine if utilisation of a POC-cTnI testing reduces ED length of stay. We also aim to establish an optimised implementation process for the amended clinical pathway.
Methods and Analysis: This quality improvement initiative has a pragmatic multihospital stepped-wedge cross-sectional cluster randomised design. Consecutive patients presenting to the ED with symptoms suggestive of possible AMI and having a cTn test will be included. Clusters (comprising one or two hospitals each) will change from their usual-care pathway to an amended pathway using POC-cTnI-the 'intervention'. The dates of change will be randomised. Changes occur at 1 month intervals, with a minimum 2 month 'run-in' period. The intervention pathway will use a POC-cTnI measurement as an alternate to the laboratory-based cTn measurement. Clinical decision-making steps and logic will otherwise remain unchanged. The POC-cTnI is the Siemens (Erlangen Germany) Atellica VTLi high-sensitivity cTnI assay. The primary outcome is ED length of stay. The safety outcome is cardiac death or AMI within 30 days for patients discharged directly from the ED.
Ethics and Dissemination: Ethics approval has been granted by the New Zealand Southern Health and Disability Ethics Committee, reference 21/STH/9. Results will be published in a peer-reviewed journal. Lay and academic presentations will be made. Māori-specific results will be disseminated to Māori stakeholders.
Trial Registration Number: ACTRN12619001189112.
Competing Interests: Competing interests: Siemens Healthcare had no part in the writing of the protocol, and will play no part in the data analysis, interpretation or writing of manuscripts. JWP reports consultancy with Upstream, Luminoma, Siemens Healthineers, Quidel Corporation and Radiometer Health. NM has received honoraria from Abbott Diagnostics, Roche Diagnostics, Siemens Healthineers and LumiraDx and the University of Edinburgh have received research grants from Siemens Healthineers and Abbott Diagnostics unrelated to this work. LC has received honoraria/speakers’ fees from Abbott Diagnostics, Beckman Coulter and Siemens Healthineers, and institutional research grants from Siemens Healthineers, Beckman Coulter and Abbott Diagnostics unrelated to this work. ASJ reports work with all major diagnostic companies. FP reports research grants with Brainbox, Quidel; Consultancies with Abbott, Brainbox, Instrument Labs, Janssen, Osler, Roche, Siemens, Spinchip, Vifor; Stock/Ownership Interests with AseptiScope, Brainbox, Braincheck, Coagulo, Comprehensive Research Associates LLC, Comprehensive Research Management, Emergencies in Medicine LLC, Fast, Forrest Devices, Ischemia DX LLC, Lucia, Prevencio, RCE Technologies, ROMTech, ScPharma, Trivirum, Upstream. MT has received honoraria and research funding from Abbott, Alere, Beckman, QuidelOrtho, Radiometer, Roche and Siemens.
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